Metformin Combined With Chemotherapy for Pancreatic Cancer

Plain-language summary

This Phase 2 study examines, compared with placebo, the effect of adding the drug metformin to chemotherapy with gemcitabine and erlotinib in patients with advanced pancreatic cancer. It included patients over 18 with tissue-confirmed, metastatic pancreatic cancer. It was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Intervention

gemcitabine, erlotinib, metformin, placebo

Start date

8/1/2010

Estimated completion

4/1/2014

Countries

Netherlands

Related genes

Locations

• Amsterdam, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Signed informed content obtained prior to treatment
* Cytological or histological confirmed carcinoma of the pancreas
* Metastatic cancer
* Measurable lesion according to RECIST criteria
* ECOG/ WHO performance 0-2
* Age \> 18 years
* Adequate renal function (creatinine \< 150 µmol/L and/ or a creatinine clearance \> 60 ml/ L)
* Adequate liver function (bilirubin \< 1.5 times upper limit of normal, ALAT or ASAT \< 5.0 times upper limit of normal in case of liver metastases and \< 2.5 the upper limit of normal in absence of liver metastases).
* Adequate bone marrow function (WBC \> 3.0 x 10 9/L, platelets \> 100 x 10 9/L)
* Mentally, physically, and geographically able to undergo treatment and follow up

Exclusion Criteria:

* Clinical or radiological evidence of CNS metastases
* Pregnancy (positive serum pregnancy test) and lactation
* Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
* Patients who have any severe and/or uncontrolled medical conditions:

  * unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to randomization, serious uncontrolled cardiac arrhythmia
  * uncontrolled diabetes as defined by fasting serum glucose \>2X ULN.
  * active or uncontrolled severe infection.
  * cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  * severely impaired lung function
* Previous treatment with erlotinib
* Previous treatment with gemcitabine for metastatic disease
* Previous treatment with gemcitabine combined with radiotherapy for locally advanced pancreatic cancer within 6 months prior to study entry
* Patients with a known hypersensitivity to metformin
* Use of metformin in the previous 6 months